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. 2023 Dec;84(6):547-560.
doi: 10.1016/j.eururo.2023.06.013. Epub 2023 Jul 5.

Primary Whole-gland Ablation for the Treatment of Clinically Localized Prostate Cancer: A Focal Therapy Society Best Practice Statement

Sriram Deivasigamani  1 , Srinath Kotamarti  1 , Ardeshir R Rastinehad  2 , Rafael Sanchez Salas  3 , J J M C H de la Rosette  4 , Herbert Lepor  5 , Peter Pinto  6 , Hashim U Ahmed  7 , Inderbir Gill  8 , Laurence Klotz  9 , Samir S Taneja  5 , Mark Emberton  10 , Nathan Lawrentschuk  11 , James Wysock  5 , John F Feller  12 , Sebastien Crouzet  13 , Praveen Kumar M  14 , Denis Seguier  15 , Eric S Adams  1 , Zoe Michael  1 , Andre Abreu  8 , Kae Jack Tay  16 , John F Ward  17 , Katsuto Shinohara  18 , Aaron E Katz  5 , Arnauld Villers  19 , Joseph L Chin  20 , Phillip D Stricker  21 , Eduard Baco  22 , Petr Macek  23 , Ardalan E Ahmad  24 , Peter K F Chiu  25 , E David Crawford  26 , Craig G Rogers  27 , Jurgen J Futterer  28 , Soroush Rais-Bahrami  29 , Cary N Robertson  1 , Boris Hadaschik  30 , Giancarlo Marra  31 , Massimo Valerio  32 , Kian Tai Chong  33 , Veeru Kasivisvanathan  10 , Wei Phin Tan  5 , Derek Lomas  34 , Jochen Walz  35 , Gustavo Cardoso Guimaraes  36 , Nikos I Mertziotis  37 , Ezequiel Becher  38 , Antonio Finelli  9 , Ali Kasraeian  39 , Amir H Lebastchi  8 , Anup Vora  40 , Mark A Rosen  41 , Baris Bakir  42 , Rohit Arcot  43 , Samuel Yee  25 , Christopher Netsch  44 , Xiaosong Meng  45 , Theo M de Reijke  46 , Yu Guang Tan  16 , Stefano Regusci  47 , Tavya G R Benjamin  2 , Ruben Olivares  48 , Mohamed Noureldin  49 , Fernando J Bianco  50 , Arjun Sivaraman  51 , Fernando J Kim  52 , Robert W Given  53 , Shawn Dason  54 , Tyler J Sheetz  54 , Sunao Shoji  55 , Ariel Schulman  56 , Peter Royce  57 , Taimur T Shah  7 , Stephen Scionti  58 , Georg Salomon  59 , Pilar Laguna  4 , Rafael Tourinho-Barbosa  60 , Alireza Aminsharifi  61 , Xavier Cathelineau  23 , Paolo Gontero  31 , Armando Stabile  62 , Jeremy Grummet  57 , Leila Ledbetter  1 , Margaret Graton  1 , J Stephen Jones  63 , Thomas J Polascik  64 ; Focal Therapy Society
Affiliations

Primary Whole-gland Ablation for the Treatment of Clinically Localized Prostate Cancer: A Focal Therapy Society Best Practice Statement

Sriram Deivasigamani et al. Eur Urol. 2023 Dec.

Abstract

Context: Whole-gland ablation is a feasible and effective minimally invasive treatment for localized prostate cancer (PCa). Previous systematic reviews supported evidence for favorable functional outcomes, but oncological outcomes were inconclusive owing to limited follow-up.

Objective: To evaluate the real-world data on the mid- to long-term oncological and functional outcomes of whole-gland cryoablation and high-intensity focused ultrasound (HIFU) in patients with clinically localized PCa, and to provide expert recommendations and commentary on these findings.

Evidence acquisition: We performed a systematic review of PubMed, Embase, and Cochrane Library publications through February 2022 according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement. As endpoints, baseline clinical characteristics, and oncological and functional outcomes were assessed. To estimate the pooled prevalence of oncological, functional, and toxicity outcomes, and to quantify and explain the heterogeneity, random-effect meta-analyses and meta-regression analyses were performed.

Evidence synthesis: Twenty-nine studies were identified, including 14 on cryoablation and 15 on HIFU with a median follow-up of 72 mo. Most of the studies were retrospective (n = 23), with IDEAL (idea, development, exploration, assessment, and long-term study) stage 2b (n = 20) being most common. Biochemical recurrence-free survival, cancer-specific survival, overall survival, recurrence-free survival, and metastasis-free survival rates at 10 yr were 58%, 96%, 63%, 71-79%, and 84%, respectively. Erectile function was preserved in 37% of cases, and overall pad-free continence was achieved in 96% of cases, with a 1-yr rate of 97.4-98.8%. The rates of stricture, urinary retention, urinary tract infection, rectourethral fistula, and sepsis were observed to be 11%, 9.5%, 8%, 0.7%, and 0.8%, respectively.

Conclusions: The mid- to long-term real-world data, and the safety profiles of cryoablation and HIFU are sound to support and be offered as primary treatment for appropriate patients with localized PCa. When compared with other existing treatment modalities for PCa, these ablative therapies provide nearly equivalent intermediate- to long-term oncological and toxicity outcomes, as well as excellent pad-free continence rates in the primary setting. This real-world clinical evidence provides long-term oncological and functional outcomes that enhance shared decision-making when balancing risks and expected outcomes that reflect patient preferences and values.

Patient summary: Cryoablation and high-intensity focused ultrasound are minimally invasive treatments available to selectively treat localized prostate cancer, considering their nearly comparable intermediate- to long term cancer control and preservation of urinary continence to other radical treatments in the primary setting. However, a well-informed decision should be made based on one's values and preferences.

Keywords: Ablation therapy; Best practice statement; Cryotherapy; Focal Therapy Society; Functional outcomes; High-intensity focused ultrasound; Oncological outcomes; Prostate cancer; Whole-gland ablation.

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